Rio de Janeiro 1/09/08 – On Agust 26^th 2008, the  Brazilian Patent Office (INPI) rejected the patent application filed in 1998 by United States pharmaceutical company Gilead Laboratories for tenofovir disoproxil fumarate, recommended for the first and second line in the treatment of people living with HIV/AIDS. For the first time, a pre-grant opposition filed by Brazilian civil society and a public laboratory (Farmanguinhos) for an antiretroviral (ARV) has led to a patent rejection.  This sets an important precedent for oppositions filed in developing countries and is an important victory for access to medicines in Brazil.

The patent decision was based on the argument of lack of inventivness – one of the three patentability requirements. Oppositions filed were also based on technical and public health grounds by the HIV/Aids and Human Rights organizations ABIA, GAPA RS, GESTOS, CONECTAS, GIV, PELA VIDDA SP e GAPA SP in December 2006.

Access to affordable tenofovir is particularly important for Brazil, as by the end of 2008, an estimated 31,000 people living with HIV/AIDS will receive the drug through the national treatment program.  In April, the Brazilian government declared tenofovir to be of ‘public interest’ in treating people living with HIV in order to speed up the patent analysis, which started in 2000.

In Brazil, Gilead sells tenofovir for US$1,387 per patient per year, and in comparison, the cheapest available generic version manufactured in India costs only US$158 per patient per year. 

This patent rejection shows how important the safeguards in Brazil’s patent law are and how crucial it is that civil society mobilizes to make sure patents are not granted that should not be. Unnecessary patenting leads to the restriction of competition and therefore to high prices.